Catalog Number

SSR75S-01/H

Brand Name

SCOUT®

Version/Model Number

00884450500620

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

e6a8215a-cc85-4338-8d5b-19c967139a9f

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 07, 2022

Package DI Number

10884450500627

Quantity per Package

5

Contains DI Package

00884450500620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-